Miscellaneous immune disorders:
Indications for: REZUROCK
Chronic graft-versus-host disease (GVHD) after failure of ≥2 prior lines of systemic therapy.
Adult Dosage:
Swallow whole. Take with food at the same time each day. 200mg once daily until progression of chronic GVHD that requires new systemic therapy. Concomitant strong CYP3A inducers, PPIs: increase to 200mg twice daily.
Children Dosage:
<12yrs: not established.
REZUROCK Warnings/Precautions:
Monitor LFTs (total bilirubin, AST, ALT) at least monthly. Discontinue permanently if Grade 4 AST/ALT (>20×ULN), Grade ≥3 bilirubin (>3×ULN), or other Grade 4 adverse reactions occur. Withhold if Grade 3 AST/ALT (5–20×ULN), Grade 2 bilirubin (1.5–3×ULN), or other Grade 3 adverse reactions occur until recovery to Grade 0–1; then resume treatment. Pre-existing severe renal or hepatic impairment: not studied. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for ≥1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥1 week after the last dose).
REZUROCK Classification:
Kinase inhibitor.
REZUROCK Interactions:
Antagonized by strong CYP3A inducers (eg, rifampin), PPIs (eg, rabeprazole, omeprazole); increase dose (see Adult).
Adverse Reactions:
Infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, decreased phosphate, decreased lymphocytes, increased GGT, hypertension; hepatotoxicity.
Generic Drug Availability:
NO
How Supplied:
Tabs—30
